NCT02631304

Brief Summary

The purpose of this study is to assess the association between the "point-of-care" (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery. Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

December 9, 2015

Last Update Submit

April 10, 2018

Conditions

Postoperative Complications

Keywords

Postoperative deliriumCholinesterase activityButurylcholinesterase activityAcetylcholinesterase activityElderly patientsCardiac surgery

Outcome Measures

Primary Outcomes (2)

  • Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity

    The perioperative AChE and BuChE activity will be assessed in the whole blood by a "point-of-care" measuring instrument (ChE check mobile ®) and the association to the incidence and duration of postoperative delirium will be determined. It will be assessed preoperative and maximum until the 5th postoperative day (POD), minimum until the 3.POD.

    5 days

  • Delirium

    Postoperative delirium will be assessed preoperative and daily with the CAM / CAM-ICU test until the 5.POD and on the discharge day from hospital. The incidence of postoperative delirium will be associated with the perioperative AChE and BuChE time course.

    5-45 days

Secondary Outcomes (11)

  • Pre-existing patient related risk factors

    1 day

  • Identification of anticholinergic concomitant medication according to the PRISCUS list

    1 day

  • Survey of treatment associated data

    45 days

  • Cognitive function

    45 days

  • Routine venous blood parameters

    5 days

  • +6 more secondary outcomes

Other Outcomes (3)

  • Gender effect on delirium assessed by CAM-ICU/CAM

    5-45 days

  • Gender effects on the peri-operative AChE and BuChE activity

    5-45 days

  • Postoperative bleeding

    1 day

Study Arms (1)

Patients undergoing cardiac surgery

Elderly patients scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of cardiopulmonary bypass.

Procedure: Elective cardiac surgery

Interventions

Elective cardiac surgeryPROCEDURE

Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery

Patients undergoing cardiac surgery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Tertiary care clinic

You may qualify if:

  • Written informed consent
  • ≥ 65 years of age
  • Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB
  • Both genders

You may not qualify if:

  • Planned deep hypothermic arrest
  • Acute / emergency procedures
  • Surgery without extracorporeal circulation (ECC)
  • Patients with a history of pseudocholinesterase deficiency
  • Employees of the respective study centres
  • Illiteracy
  • Severe communication difficulties and severe vision or hearing problems
  • Patients legally unable to give written informed consent
  • non-fluency in German language
  • Severe psychiatric or neuropsychiatric disorders
  • MMSE \< 24 points, short geriatric depression scale (GDS) ≥ 10 points
  • Recent (\<6 months) history of alcohol or drug abuse
  • The participation in a drug or device trial within the previous 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (7)

  • Smulter N, Lingehall HC, Gustafson Y, Olofsson B, Engstrom KG. Delirium after cardiac surgery: incidence and risk factors. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):790-6. doi: 10.1093/icvts/ivt323. Epub 2013 Jul 25.

    PMID: 23887126BACKGROUND

  • Cerejeira J, Batista P, Nogueira V, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. Low preoperative plasma cholinesterase activity as a risk marker of postoperative delirium in elderly patients. Age Ageing. 2011 Sep;40(5):621-6. doi: 10.1093/ageing/afr053. Epub 2011 May 15.

    PMID: 21576115BACKGROUND

  • Rudolph JL, Inouye SK, Jones RN, Yang FM, Fong TG, Levkoff SE, Marcantonio ER. Delirium: an independent predictor of functional decline after cardiac surgery. J Am Geriatr Soc. 2010 Apr;58(4):643-9. doi: 10.1111/j.1532-5415.2010.02762.x. Epub 2010 Mar 22.

    PMID: 20345866BACKGROUND

  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774BACKGROUND

  • Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. The immunology of delirium. Neuroimmunomodulation. 2014;21(2-3):72-8. doi: 10.1159/000356526. Epub 2014 Feb 14.

    PMID: 24557038BACKGROUND

  • Distelmaier K, Winter MP, Rutzler K, Heinz G, Lang IM, Maurer G, Koinig H, Steinlechner B, Niessner A, Goliasch G. Serum butyrylcholinesterase predicts survival after extracorporeal membrane oxygenation after cardiovascular surgery. Crit Care. 2014 Jan 30;18(1):R24. doi: 10.1186/cc13711.

    PMID: 24479557BACKGROUND

  • Arbel Y, Shenhar-Tsarfaty S, Waiskopf N, Finkelstein A, Halkin A, Revivo M, Berliner S, Herz I, Shapira I, Keren G, Soreq H, Banai S. Decline in serum cholinesterase activities predicts 2-year major adverse cardiac events. Mol Med. 2014 Feb 12;20(1):38-45. doi: 10.2119/molmed.2013.00139.

    PMID: 24395570BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Postoperative ComplicationsEmergence Delirium

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Ana Stevanovic, MD

    Department of Anesthesiology, University Hospital Aachen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ana Stevanovic

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 16, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

DE(1)